NAFLDTRELNCT04997486
The Effect of Time-restricted Eating on Liver Metabolism
A study testing Time restricted eating in people with NAFLD and Obesity, run by University of California, Davis at 1 site in United States.
Trial summary
Numerous studies have established the role of nutrition on obesity and its related metabolic diseases, which together affect a billion individuals worldwide. Evidence indicate that meal timing regulates numerous metabolic processes suggesting that meal time manipulation may be a simple intervention against obesity and… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- NAFLD, Obesity, Nutritional and Metabolic Diseases
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 25-75 years
- men and women
- body mass index 25-45 kg/m2
- clinical diagnosis of NAFLD
- self-reported habitual eating period more than or equal to 14 h per day.
Who cannot join
- shift worker, recent or expected travel crossing time zones
- fasting >12-h/day more than once a week
- > once a week no food intake after 18:00
- habitually waking up before 04:00 and sleeping before 22:30
- unstable weight (>5% change in the last 2 months)
- diabetes mellitus or alcoholic liver disease
Show all 19Show fewer
- sleep disorder
- history of or current eating disorder
- cancer in last 5 years
- conditions that render subject unable to complete all testing procedures
- use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued
- smoking or illegal drug use
- pregnant or breastfeeding
- having metals in the body
- cognitive impairment
- gastrointestinal or bariatric surgery that affects nutrient digestion and absorption unable to grant voluntary informed consent or comply with the study instructions individuals who are not yet adults (infants, children, teenagers)
- individuals that are unable to lie motionless on the MRI scanner for an hour or *have tattoos or tattooed eyeliner
- alcohol abuse
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616-5398
About this study
Numerous studies have established the role of nutrition on obesity and its related metabolic diseases, which together affect a billion individuals worldwide. Evidence indicate that meal timing regulates numerous metabolic processes suggesting that meal time manipulation may be a simple intervention against obesity and its metabolic diseases. Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-10 h/day with no energy intake the rest of the day. In rodents, TRE significantly decreases hepatic steatosis and dyslipidemia, while it supports a healthier hepatic cellular content even without caloric restriction, potentially by alternating activation of nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on liver health in people is not clear. Accordingly, we will conduct a randomized controlled trial in people with overweight/obesity and hepatic steatosis to determine the effect of 9 h TRE for 12 weeks, on key metabolic outcomes in liver health: 1) intrahepatic triglyceride content using magnetic resonance imaging; 2) de novo lipogenesis during fasting and postprandial conditions using administration of deuterated water in conjunction with mathematical modeling. The proposed study will enable us to determine the effect of meal timing on metabolic function in people with NAFLD.
- Conditions
- NAFLD, Obesity, Nutritional and Metabolic Diseases
- Being tested
- Time restricted eating
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Participants will be asked consume all meals/snacks during a ~9-h daily eating period (~15-h fasting).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects will consume all meals/snacks during a ~15-h daily eating period (~9-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance. |
| TRE isocaloric | Experimental | Subjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance. Receives: Behavioral: Time restricted eating |
| TRE ad libitum | Experimental | Subjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting) without any other dietary advice. Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intrahepatic triglyceride (IHTG) content
IHTG will be assessed by using MRI
Measured: About 12 weeks
Change in de novo lipogenesis (DNL)
DNL will be assessed by using administration of deuterated water and measurement of deuterium enrichment in plasma lipids
Measured: About 12 weeks
Change in glucose, free fatty acid and triglyceride levels in response to a meal
Postprandial metabolic homeostasis will be assessed by using a mixed meal tolerance test.
Measured: Before and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start20 Jul 2021
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997486
- Sponsor's protocol ID
- 1757716
- Acronym
- TREL
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-restricted Eating on Liver Metabolism
- ClinicalTrials.gov ID
- NCT04997486
- Acronym / sponsor ID
- TREL / 1757716
- Conditions
- NAFLD, Obesity, Nutritional and Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous studies have established the role of nutrition on obesity and its related metabolic diseases, which together affect a billion individuals worldwide. Evidence indicate that meal timing regulates numerous metabolic processes suggesting that meal time manipulation may be a simple intervention against obesity and its metabolic diseases. Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-10 h/day with no energy intake the rest of the day. In rodents, TRE significantly decreases hepatic steatosis and dyslipidemia, while it supports a healthier hepatic cellular content even without caloric restriction, potentially by alternating activation of nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on liver health in people is not clear. Accordingly, we will conduct a randomized controlled trial in people with overweight/obesity and hepatic steatosis to determine the effect of 9 h TRE for 12 weeks, on key metabolic outcomes in liver health: 1) intrahepatic triglyceride content using magnetic resonance imaging; 2) de novo lipogenesis during fasting and postprandial conditions using administration of deuterated water in conjunction with mathematical modeling. The proposed study will enable us to determine the effect of meal timing on metabolic function in people with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects will consume all meals/snacks during a ~15-h daily eating period (~9-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance. |
| TRE isocaloric | Experimental | Behavioral: Time restricted eatingSubjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance. |
| TRE ad libitum | Experimental | Behavioral: Time restricted eatingSubjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting) without any other dietary advice. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 25-75 years
- men and women
- body mass index 25-45 kg/m2
- clinical diagnosis of NAFLD
- self-reported habitual eating period more than or equal to 14 h per day.
Key exclusion criteria (19 listed)
- shift worker, recent or expected travel crossing time zones
- fasting >12-h/day more than once a week
- > once a week no food intake after 18:00
- habitually waking up before 04:00 and sleeping before 22:30
- unstable weight (>5% change in the last 2 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingParticipants will be asked consume all meals/snacks during a ~9-h daily eating period (~15-h fasting). | Behavioural | TRE ad libitum, TRE isocaloric |
Primary outcome
Change in Intrahepatic triglyceride (IHTG) content
Time frame: About 12 weeks
IHTG will be assessed by using MRI
Change in de novo lipogenesis (DNL)
Time frame: About 12 weeks
DNL will be assessed by using administration of deuterated water and measurement of deuterium enrichment in plasma lipids
Change in glucose, free fatty acid and triglyceride levels in response to a meal
Time frame: Before and after 12 weeks
Postprandial metabolic homeostasis will be assessed by using a mixed meal tolerance test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with NAFLD and Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intrahepatic triglyceride (IHTG) content (time frame: About 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.